A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults
A Phase II Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults
1 other identifier
interventional
272
1 country
14
Brief Summary
To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV (intravenous) to Chinese adults (including those with stable medical conditions).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2021
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2021
CompletedStudy Start
First participant enrolled
December 3, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2023
CompletedResults Posted
Study results publicly available
November 21, 2024
CompletedNovember 21, 2024
September 1, 2024
9 months
November 17, 2021
August 8, 2023
September 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events of Special Interest
Adverse events of special interest are events of scientific and medical interest, specific to the further understanding of the study intervention safety profile, and require close monitoring and rapid communication by the investigators to the sponsor.
recorded from the time of signature of the ICF up to 245 days
Secondary Outcomes (1)
Serum Concentrations of AZD7442 Over Time
recorded from the time of signature of the ICF through the last participant contact. Protocol-specified timepoints include Pre-dose, Day 1, Day 8, Day 31, Day 61, Day 91, Day 181, Day 271, and Day 361.
Study Arms (2)
AZD7442
EXPERIMENTALco-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Placebo
PLACEBO COMPARATORco-administration of a single dose of 600mg placebo by intravenous (IV) infusion.
Interventions
Participants will be randomized to receive co-administration of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by a single IV infusion.
Participants will be randomized to receive co-administration of 600mg placebo by a single IV infusion.
Eligibility Criteria
You may qualify if:
- Adults ≥ 18 years
- Negative results of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative reverse transcriptase polymerase chain reaction (qRT-PCR)
- Healthy or medically stable participants
- Contraceptive within 365 days post dosing
You may not qualify if:
- Medical condition:
- Known hypersensitivity to monoclonal antibody (mAb) or investigational product (IP) component.
- Acute illness including fever on the day prior to or day of dosing.
- Any other significant disease increase the risk to participant study.
- Laboratory related:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.0 × upper limit of normal (ULN), alkaline phosphatase (ALP) \> 1.5 × ULN, or TBL (total bilirubin) \> 1.5 × ULN (unless due to Gilbert's syndrome).
- Serum creatinine \> 176 μmol/L.
- Haemoglobin \< 10g/dL.
- Platelet count \< 100 × 10\^3/μL.
- White blood cell count \< 3.5 × 10\^3/μL or neutrophil count \< 1.5 × 10\^3/μL.
- Other laboratory significantly abnormal in the screening panel that, in the opinion of the investigator, will increase participants risk or might confound analysis of study results.
- COVID-19 infection history/any receipt of mAb indicated for COVID-19.
- Prior/concomitant treatment: Receipt of any investigational product within 90 days or 5 antibody half-lives (whichever is longer) prior to Day 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (14)
Research Site
Baoding, 071000, China
Research Site
Beijing, 100034, China
Research Site
Changsha, 410008, China
Research Site
Chongqing, 400016, China
Research Site
Fuzhou, 350005, China
Research Site
Haikou, 570311, China
Research Site
Hangzhou, 310006, China
Research Site
Lanzhou, 730030, China
Research Site
Shanghai, 200040, China
Research Site
Shanghai, 200080, China
Research Site
Shanghai, 200120, China
Research Site
Suzhou, 215004, China
Research Site
Ürümqi, 830054, China
Research Site
Xuzhou, 221000, China
Related Publications (2)
Zhang J, Zhang H, Zhang Y, Liu S, Ge X, Zhang H, Li Y, Chen CC, Stepanov O, Tang W, Zhang W. Safety and Pharmacokinetics of Long-Acting Monoclonal Antibodies Tixagevimab and Cilgavimab (AZD7442) in a China Phase 2 Study and Evaluation of Asian Race Effect. Clin Pharmacol Drug Dev. 2025 Nov;14(11):846-855. doi: 10.1002/cpdd.1586. Epub 2025 Sep 5.
PMID: 40910575DERIVEDHirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
PMID: 35713300DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- AstraZeneca Clinical Study Information Center
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2021
First Posted
January 11, 2022
Study Start
December 3, 2021
Primary Completion
August 15, 2022
Study Completion
May 6, 2023
Last Updated
November 21, 2024
Results First Posted
November 21, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.